Cleared Traditional

K890207 - INTERVENTIONAL PRODUCTS - GUIDE WIRES

K890207 is the FDA 510(k) clearance for INTERVENTIONAL PRODUCTS - GUIDE WIRES by E-Z-Em, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K890207 · E-Z-Em, Inc. · Cardiovascular device
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May 1989
Decision
134d
Days
Class 2
Risk

K890207 is an FDA 510(k) clearance for the INTERVENTIONAL PRODUCTS - GUIDE WIRES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Marlboro, US). The FDA issued a Cleared decision on May 31, 1989 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K890207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1989
Decision Date May 31, 1989
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 509
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K890207.
USCI PROBE LINX EXTENSION WIRE
K890404 · C.R. Bard, Inc. · Aug 1989
USCI GREY/BLACK GUIDE WIRE
K890505 · C.R. Bard, Inc. · Jun 1989
GUIDE WIRE INTRODUCER
K890807 · Datascope Corp. · Jun 1989
KATZEN THROMBOLYSIS GUIDEWIRE
K883880 · Medi-Tech, Inc. · Apr 1989
ACS 0.015 & 0.018 PRESSURE GUIDE WIRE W/MICRO.
K882507 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · Advanced Cardiovascular Systems, Inc. · Feb 1989